Service life timer for a device for administering a product in doses

ABSTRACT

An injection device including at least one sensor for detecting an operating process of the injection device, an electronic circuit connected to the sensor for establishing the beginning and elapsed time of a service life, based on one or more sensor signals, and an output device connected to the circuit for providing a signal indicating the end of the service life. The invention encompasses a method for determining a service life of an injection device, wherein the beginning of the service life is established by one or more sensors for detecting an operating process of the device, a signal is generated which signals the end of the service life, and at least one of an optical, acoustic or tactile output device is associated with the injection device for providing a signal which indicates the end of the service life.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation of U.S. Ser. No. 11/316,388 filedDec. 22, 2005, which claims the benefit of German Patent Application No.DE 10 2004 063 650.8, filed on Dec. 31, 2004, the contents of which areincorporated herein by reference in its entirety.

BACKGROUND

The present invention relates to devices for delivering substances andmethods of making and using them. More particularly, it relates tomedical devices for administering or delivering a product in doses, suchas injection apparatus, syringes, injection pens, etc., using which adosed amount of a fluid product, such as insulin, growth hormones orosteoporosis preparations, etc., can be self-administered by a user.

The functional elements of an electronic or mechanical real-time displayand of an electronic life timer or device service life timer, asdescribed below, may be used together with an injection pen as describedin a US patent application entitled “Injection or Infusion ApparatusComprising a Service Life Timer” filed on the same day as the presentapplication and owned by the owner of the present application. Theelements and functional sub-assemblies of injection apparatus, asdescribed in that patent application, are incorporated into thisapplication by reference, wherein an injection pen in accordance withthe present invention may incorporate an embodiment of a dosage displaydescribed in the referenced patent application, and/or with regard tosensors, electronics or display elements as described herein.

In injection devices, including pen-type devices, components such assprings or components which are often moved can wear, change ordeteriorate due to the strains occurring during use and due tomechanical stresses, and also due to aging processes, such that thecorrect mode of operation and functional capability of the pen iscompromised.

If a user sets a dosage or an amount of a substance to be dispensed bythe injection device by displacing the substance from an ampouleinserted in the injection device, then it is advantageous for the userif the dosage currently can be set and/or displayed on a display of theinjection device. In known injection apparatus, the dosage set isdisplayed during and after setting the dosage, and the user can initiatethe injection process by pressing a triggering button, wherein thedosage displayed rotates or runs back or is reset from the dosage set tozero after the injection process has been performed.

SUMMARY

It is one object of the present invention to provide a device and amethod for monitoring, assessing and/or determining the service life ofan injection pen and the end of the service life can be displayed.

It is another object of the present invention to propose a device and amethod which provide the user of an injection device with additionalinformation for performing an injection process which has beeninterrupted.

In one embodiment, the present invention comprises an injection deviceincluding at least one sensor for detecting an operating process of theinjection device, an electronic circuit connected to the sensor forestablishing the beginning and elapsed time of a service life, based onone or more sensor signals, and an output device connected to thecircuit for providing a signal indicating the end of the service life.The invention encompasses a method for determining and/or monitoring aservice life of an injection device, wherein the beginning of theservice life is established by one or more sensors for detecting anoperating process of the device, a signal is generated which signals theend of the service life, and at least one of an optical, acoustic ortactile output device is associated with the injection device forproviding a signal which indicates the end of the service life.

In accordance with one embodiment of the present invention, an injectiondevice comprises at least one sensor in order to detect at least onedose setting or other operating process of the injection device. Amechanical switch or pressure switch can, for example, be provided as asensor on the injection device in the region of a dosing member, aninjection button or other suitable location, to detect, for example,when the injection device is activated for the first time or when anampoule is inserted. It is also possible for a sensor or switchingelement to be provided at another point on the injection device, such asin the region of a reservoir into which an ampoule is inserted, orcoupled via a connecting member to a component of the injection device,to detect when an ampoule is inserted. It is also possible to provide anencoder or rotational sensor as the sensor, which may be coupled to adosing member, a piston rod or threaded rod of the injection device bymeans of a suitable engagement, for example, via a spur wheel, a toothedring or a toothed wheel, mounted approximately parallel to the centralaxis of the injection device, to detect a setting or delivery process ofthe injection device.

In accordance with an embodiment of the present invention, any sensorcan in principle be used which is suitable for detecting when theinjection device is activated or operated for the first time, or usingwhich an operating process or activating process of the injectiondevice, for example for setting a dosage to be dispensed, for drawing upthe injection device, for preparing an injection process, for performingan injection process, for delivering a set dosage or for changing anampoule, can be detected. By means of one or more such sensors forqualitatively or quantitatively detecting operating processes,operational or state parameters, it is possible to detect when aninjection device has been activated or operated for the first time, tostart a timer provided in the injection device, which, after a fixedtime period, for example three years, predetermined by the manufacturer,outputs a signal in order to indicate that the service life of theinjection device—for which the manufacturer of the injection deviceguarantees the correct mode of operation of the injection device—haselapsed.

Such a timer may be based on mechanical or chemical principles, whereinfor example a chemical substance which changes its colour after apredetermined time period can be provided such that a user can recognisefrom the colour whether the injection device has exceeded therecommended or indicated service life.

In such embodiments, a timer is provided or enabled by an electroniccircuit connected to at least one of the sensors described above andreceives a start signal from one or more of these sensors, for examplewhen the injection device is activated for the first time or when a fullampoule is inserted. Once a time period predetermined or set by themanufacturer, user or calculated by the circuit has elapsed, taking intoaccount stresses on the injection device, the circuit outputs a signalto a display or a lamp, to indicate to a user that the end of theservice life of the injection device has been reached.

When, once the timer has elapsed, it is established that the servicelife of the injection device has elapsed, then it is possible togenerate one of an optical, acoustic and/or tangible or tactile signalin order to indicate to the user that injection device should no longerbe used for safety reasons. However, the injection device can inprinciple continue to be used, wherein for example a correspondingwarning signal, such as for example the illumination or blinking of ared LED or OLED, can be generated in the process of use. Alternatively,it is also possible for a stop signal outputted by an electrical ormechanical circuit, to an actuator such as an electromotor, a magneticswitch or a locking element, to be outputted once the end of the servicelife of the injection device has been established, such that theactuator places the injection device in a state in which it can nolonger be used and in which no further dosages can be dispensed, i.e.,for example blocking or locking a rotatable setting element, permanentlydecoupling functional sub-assemblies of the injection device which haveto be coupled to each other during a setting or dispensing process, orpreventing an injection button from being activated by creating apermanent, fixed connection between the injection button and theinjection device.

In some embodiments a data memory can also be provided in the injectiondevice, together with a timer, in which data can be stored relating tothe service life, setting or operating processes performed on theinjection device. Such data may relate to the time when the injectiondevice was operated for the first time, the number and/or time of thedosage setting processes and/or delivery processes, and/or the numberand/or times of ampoule changes. A processor or controller provided inthe injection device can compare the data on the use of the injectiondevice stored in the memory with limit values for the maximumpermissible use of the injection device, fixedly predetermined or set bythe manufacturer, in order to output a signal when the maximumpermissible number of ampoule changes or delivery processes has beenreached or exceeded, in order to generate a warning signal as describedabove, which indicates to the user that the maximum number of ampoulechanges or delivery processes has been reached or exceeded. If operatingor operational parameters of the injection device are used to ascertainthe end of the service life of the injection device, then the servicelife time period can vary depending on how the injection device is usedby the user.

It is also possible for the end of the service life to be ascertained bytaking into account various parameters, such that the service life of aninjection pen which is not used ends after a predetermined time period,for example three years, wherein for each operating process of theinjection device detected by one or more sensors, such as an ampoulechange or a delivery process, a predetermined time period is deductedfrom the maximum service life, such that a pen which is used often afterit has been operated for the first time generates a signal indicatingthat the end of the service life has been reached earlier than a penwhich is only rarely used.

If the life timer is controlled via the number of ampoule changesdetected by a sensor, then a so-called system check can additionally beperformed. If the ampoule is full, then a switch of the life timer isactivated via the threaded rod and a connecting piece, which brieflyilluminates the LED green.

In some preferred embodiments the display for the user that the end ofthe service life has been reached is an optical display and can comprisethe electronic, mechanical or electro-mechanical display provided fordisplaying a dosage set, such as an LCD display and—additionally oralternatively—one, two or more counting rings or counting discs, onwhich a signal is directly generated or set which indicates the end ofthe service life to a user. A lamp, such as an LED, OLED, other suitablelight source, can also be provided which is illuminated or blinks forthe first time or changes the colour when the end of the service lifehas been reached.

Thus, for example, a multi-coloured OLED or LED or a red LED can beprovided on or in the injection device, provided next to a green LED forilluminating a setting display, in order to indicate to a user, who isusually looking at the setting display, by a red light that theinjection device should no longer be used. One or more OLEDs or LEDs canbe provided behind an LCD display or within coaxially arranged and atleast partially or completely transparent counting rings or countingdiscs for displaying the dosage, such that the red light of the LED orOLED shines through the transparent counting rings or counting discs.Another lamp can be provided in the vicinity of or next to a lamp fordisplaying the end of the service life, which is illuminated in adifferent colour and/or emits light of a different intensity as comparedto the service life displaying lamp. For example, a green LED may beilluminated behind an electronic or mechanical display when a sensorestablishes that a user is activating a setting or activating element ofthe injection device, whereby the user can read the dosage set, even indarkness or poor lighting conditions. Once the end of the service lifehas been ascertained, this lamp can be permanently switched off orswitched to emitting different-coloured light, such that the servicelife ending display or lamp blinks or is illuminated permanently or onceit is been detected that the user is operating or setting the injectiondevice. Thus, a user does not see the green light which is usuallyperceives during a setting process, but rather can recognise from thered light and/or a blinking light then generated that the end of theservice life of the injection device has been reached and that itconsequently should no longer be used, even if it is in principlepossible to continue to use the injection device.

In order to supply the sensors, circuits, controllers, processors,memories or displays provided in the injection device with energy asuitable power source may be provided, e.g., a battery, a button cell ora power pack which can be charged up, wherein the optical displayelements described above can also be used to indicate to a user that thepower pack should be charged up again.

The present invention also relates to a method for determining assessingand/or monitoring the service life or service life interval of aninjection device, wherein a beginning of the service life is ascertainedby a sensor by detecting an operating process by a user, and wherein thesensor generates a signal which defines a time at which the service lifebegins. Once it has been established that the predetermined servicelife, or a recalculated service life shortened by operating processes orother parameter, has elapsed, an optical and/or acoustic signal isgenerated immediately or at the next detected operating process, whichcan indicate the end of the service life to a user.

The present invention also relates to a computer program or an algorithmfor performing, controlling or enabling, using any task or function canbe performed, i.e., calculating a service life by taking into accountthe operating processes which shorten the service life, such asinjection processes or ampoule changes.

In accordance with another aspect, the present invention relates to aninjection device comprising a real-time display for continuouslydisplaying a dosage set for dispensing by the injection device and stillto be dispensed. An injection device in accordance with the presentinvention, in which a substance to be dispensed is contained or can beinserted in an ampoule, comprises a setting element such as a dosingbutton or dosing member which can set or define a dosage provided fordispensing or injecting, by being moved, rotated or shifted, such asdrawn out. At least one sensor is also provided which is directly orindirectly connected to the setting element or a setting or dispensingmechanism of the injection device, for example coupled via toothedwheels, in order to detect the amount of a dosage of a substanceavailable for dispensing from the injection device. An evaluation unitsuch as an electrical circuit or a processor connected to the at leastone sensor can ascertain what dosage is currently set or what dosage isstill available for dispensing by the injection device on the basis ofthe setting, directly on the basis of the signals from the at least onesensor, i.e. directly from the signals, or from the chronologicalprofile of the signals, i.e. by taking into account previous signals ofthe at least one sensor. In accordance with the present invention, theevaluation unit also ascertains the amount of the dosage set and stillavailable for dispensing or delivery but not yet delivered, while thesubstance contained in the injection device is being dispensed. Adisplay connected to the evaluation unit can display the dosage set by auser, for example as a numerical value, such that the dosage set can beread on an LCD or by means of mechanically coupled counting wheels orrings. In accordance with the invention, a regressing dosage or numbercan be displayed on the display while a substance is being delivered.

A mechanical or electronic display of the injection device can thusdisplay the current value of the amount of substance already dispensedor the dosage not yet delivered or the state of the mechanism, as areal-time display.

If, for example, a delivery process is interrupted, then a user canestablish what amount of a substance has injected, or what dosage muststill be injected.

In some embodiments, an electronics unit of the injection device ispreferably constructed in modules, i.e., the injection device isdesigned such that it is possible to combine the electronics unit with amechanical or electronic display inserted or snapped on during assembly,wherein different casing shells can also subsequently be used. It isthus not necessary for the injection device to be modified in order tointegrate either a mechanical or electronic display into the injectiondevice. The electronics unit can preferably be provided as asub-assembly for directly assembling in the injection device, whichenables plastic parts and their assembly steps to be eliminated.

Using a real-time display in accordance with the invention, it is thuspossible to display both setting or correcting a dosage, delivering,and—if necessary—correcting a set dosage, during a delivery process.

By continuously measuring or calculating the amount of the substancedispensed during a delivery process and/or of the substance stillavailable for delivery and amounting to a maximum value of the dosageset, it is possible for an evaluation unit or circuit contained in theinjection device or a user reading the display to verify whether thedelivery process is proceeding correctly, is already complete, or stillhas to be performed further. A user is thus provided in real-time, i.e.immediately, with the information which enables him/her to assess whatoperational state the injection device is in, i.e., whether a partialamount of a set dosage set has already been dispensed, or what amount ofthe dosage has already been dispensed or is still to be delivered. Auser can thus also discontinue the injection in a controlled and definedway, and continue it at a later time.

In some embodiments, a sensor for detecting the dosage still to bedispensed is preferably coupled or connected to a setting element or adelivery mechanism of the injection mechanism, such as for example apiston rod or a coupler element as described in the aforementionedpatent application owned by the applicant. The sensor preferablycontinuously detects the current operational state of the injectiondevice or information and parameter, such as a rotational angle or thenumber of revolutions of a unit provided in the injection device forsetting or delivering a dosage, such as a coupler, piston rod or toothedrod. The sensor can, for example, be a rotational switch or encoderwhich preferably does not comprise a stopper. One suitable, exemplaryencoder is manufactured for example by Alps Electric Co., Ltd. of Tokyo,Japan. An encoder can detect a rotational movement of a setting elementor dosing member directly, or the rotation of a coupler sleeve or of aspur wheel or toothed wheel in engagement with the coupler sleeve,wherein the signal detected by the encoder can be processed byelectronics contained in the injection device and forwarded to an LCDfor the user to read. Such an encoder can also be used as a sensor for alife timer as described above for detecting the beginning of the servicelife or of a setting or delivery process.

The display used to display the dosage still available for delivery canbe an LCD display provided in an electronics sub-assembly or in an “Emodule” of the injection device and can be illuminated ortransilluminated by a lamp or LED as described above. A mechanicaldisplay can also be provided, for example in the form of one, two ormore counting rings such as are described in EP 0 554 996 B1 or EP 0 897728 A1, the teachings of which relating to the mechanical configurationand coupling of units counting rings and tens counting rings isincorporated by reference into this application.

In some embodiments a real-time display of the injection device can beprovided with mechanical elements as a coaxial display of two or moreadjacent counting rings which are inscribed in the circumferentialdirection with the digits “0” to “9” as is known from tachometers inmotorised vehicles or counters in cassette machines. Such a display,comprising coaxially adjacent counting rings and/or counting discs, canbe provided coaxially on the injection device, such as in the rearregion of the injection device in the vicinity of a setting button ordosing member, and coupled to such a setting button or dosing member,such that whenever a dosing member or dosing wheel is moved, themechanical display rotates with it, when dosing up, correcting a dosageor delivering. In accordance with the present invention, the mechanicaldisplay is coupled to a setting and/or delivery or dispensing mechanismof the injection device such that even during the delivery process, themechanical display displays the amount of the dosage still to bedelivered, i.e., the mechanical display counts backwards while thesubstance contained in the injection device is delivered.

In some embodiments, the mechanical counter is preferably provided witha planetary drive for rotating the counting wheels, wherein a drive discwhich is coupled to a setting element such as a dosing member or to anelement of the delivery mechanism such as a toothed rod or piston rod orto a coupler or coupler sleeve drives one, two, three or more planetarywheels which are coupled to the drive disc or mounted on the drive disc.These planetary wheels engage with a toothing provided on the outer sideof a units counting ring and so drive the units counting ring. On theinner or outer side of the units counting ring, a toothing (on teeth) isprovided in the circumferential direction, only within a range of forexample 36 degrees preferably corresponding for instance to one unitscounting increment. Thus, after each full revolution, the units countingring can drive a coupling or transferring toothed wheel engaged withsaid toothing, which after each full revolution of the units countingring drives a tens counting ring provided coaxially to the unitscounting ring, such that the tens counting ring is rotated further by apredetermined value of 36 degrees, to rotate a digit provided on thetens counting ring forwards or backwards to the position of an adjacentdigit. A hollow wheel can serve as a bearer for the units and tenscounting rings and comprises a toothing on its inner side, with whichthe planetary wheels driving the units counting ring engage. Thecoupling toothed wheel can also be mounted in the hollow wheel. Thehollow wheel is preferably mounted in the casing of the injection devicesuch that it is secured against rotating, or is integrated into it.

By defining measurements or parameters of the toothing, the transferratio of the drive disc onto the units counting ring can be defined,such that it is possible for the units counting ring to pass through 2.4revolutions for one revolution of the drive disc, though other transferratios can also be realised by correspondingly changing the toothingdistances or variations in diameter of the mutually engaging toothedwheels or encircling rows of teeth.

The counting rings can be produced from a non-transparent material or asdescribed above from a transparent material, such that the light fromone or more lamps or LEDs arranged within the counting rings can passout through the counting rings, in order to enable a user to read adosage set, even in darkness.

The present invention also relates to a method for displaying a dosageto be dispensed by an injection device after a setting process, whereina dosage set is detected and displayed and the amount of the dosagestill to be delivered is continuously measured or ascertained anddisplayed during a delivery and dispensing process, such that aregressing display can be realised during a delivery process.

In one embodiment, the display is preferably reset to “0” when theampoule is changed or when the dosage set has been delivered or when itis established—for example by a sensor and/or components of theinjection device that abut or contact each other or a stop beencompletely performed—that a further dosage can no longer be deliveredwithout another setting process. A display can thus be automaticallyzeroed after each delivery and/or ampoule change, in order to ensurethat the display or the electronics of the injection device does notlose any counting increments and is available again for a new settingprocess starting from a defined initial state. A mechanical display canbe automatically rotated back to “0” by a drive member as shown in FIGS.1A to 1C, i.e., for example a torsion spring or spiral spring, when thepen is screwed open to change the ampoule.

In some embodiments, an electronic display of the injection deviceand/or an illumination of an electronic or mechanical display, such asfor example an LED, can be switched on when a sensor establishes thatthe injection device is being activated or moved, and can be switchedoff again when a predetermined time period of, for example, 30 secondshas passed, when it is established that the injection device has notbeen activated within a predetermined time period, or when it isestablished that a delivery process is complete.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1, including FIGS. 1A to 1C, is a cross-sectional view of anembodiment of an injection device as described in the co-ownedaforementioned patent application filed on the same date as the presentapplication;

FIG. 2 depicts a sensor for an electronic life timer in the dosingbutton, in cross-section;

FIG. 3 depicts the sensor of FIG. 2 in an exploded view;

FIG. 4 depicts an embodiment of an electronic real-time display,comprising a spur wheel for coupling the sensor to the setting anddelivery mechanism;

FIG. 5, including FIGS. 5A to 5C, depicts an embodiment of an electronicreal-time display, comprising an encoder offset with respect to a dosingmember, as a sensor;

FIG. 6 depicts a coaxial real-time display driven by a planetary gear;

FIG. 7 depicts a mechanical coaxial real-time display, comprising a lifetimer;

FIG. 8 is a detailed cross-sectional view of a portion of the injectiondevice shown in FIG. 1;

FIG. 9 is a sectional view of the detail shown in FIG. 8;

FIG. 10 is a sectional view of the detail shown in FIG. 8; and

FIG. 11 is a detailed view of the region indicated by X in FIG. 9.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1A to 1C show cross-sections of an embodiment of an injectiondevice in which a life timer and/or an electronic or mechanicalreal-time display may be integrated.

With regard to fastening, mounting, attaching or connecting thecomponents of devices of the present invention, unless specificallydescribed as otherwise, conventional fasteners such as screws, rivets,toggles, pins and the like may be used. Other fastening or attachmentmeans appropriate for connecting components include friction fitting,adhesives, welding and soldering, the latter particularly with regard toelectrical or processing components or systems of the devices. Anysuitable electronic, electrical, communication, computer or processingcomponents may be used, including any suitable electrical components andcircuitry, display components, wires, wireless components, sensors,chips, boards, micro-processing or control system components, software,firmware, hardware, etc.

FIGS. 1A to 1C show an embodiment of an injection apparatus inaccordance with a US patent application entitled “Injection or InfusionApparatus Comprising a Service Life Timer” filed on the same day as thepresent application and owned by the owner of the present application.When using the depicted device for administering, the drive force fordelivering the product is not applied manually, but rather by a drivemember 25 formed as a drive spring. The drive member 25 is a spiralspring acting as a torsion spring, comprising spring windings whichencircle the threaded axis of the threaded engagement between thecoupler output member 9 and the piston rod 15. The spring windings arearranged one over the other, radially with respect to the threaded axis;they exhibit a zero pitch with respect to the threaded axis. An innerend of the spring windings is fastened to the coupler input member 6′,and an outer end is fastened to a fastening structure 26 which isconnected to the casing part 4 such that it can be moved in thedirection of the coupler movement X but is secured against rotating. Onthe other hand, the fastening structure 26 is connected to the couplerinput member 6′ such that it cannot be moved in and counter to thedirection of the coupler movement X. The coupler input member 6′ can berotated about the threaded axis relative to the fastening structure 26.

The functionality of the coupler corresponds to that of the secondexemplary embodiment of the parallel patent application, such that thesame reference signs are used for the coupler members and the decouplingmember 11′. Unlike the coupler of the second exemplary embodiment,however, the coupler sleeve 8′ therein has been omitted. The couplerintermediate member 7′ is directly in an engagement with the coupleroutput member 9 which transfers the rotational drive movement of thecoupler input member 6′ onto the coupler output member 9.

In the embodiment shown in FIGS. 1A to 1C, the holding means is formedin a third variant. It includes a restoring element 19, as well as thecoupler receptacle which again forms the linear guide 4 a for the pistonrod 15, and a supporting structure 6 d which is connected to the couplerinput member 6′ such that it cannot be moved at least in and counter tothe direction of the coupler movement X; in the exemplary embodiment,the coupler input member 6′ and the supporting structure 6 d are formedintegrally. The drive member 25 is axially enclosed by the supportingstructures 6 d and 26. The restoring element 19 is supported on thecasing part 4 via the coupler receptacle in the direction of the couplermovement and on the supporting structure 6 d counter to the direction ofthe coupler movement X. The restoring element 19 exerts an elasticrestoring force, acting counter to the coupler movement X, on thecoupler input member 6′. It again acts as a pressure spring.

The equalising spring 17, tensed between the piston rod 15 and theconnecting part 33, supports the restoring element 19. The equalisingspring 17 could in principle replace the restoring element 19 forretracting the coupler members 6′, 7′ and 9. Preferably, however, it isweak enough that, at least once it has been partially relaxed, it can nolonger hold the coupler members in the holding position, and thus can nolonger hold the coupler in the decoupled state, with sufficientcertainty.

20″ indicates a dosage display which is coupled to the coupler inputmember 6′ via a display coupling member or units counting ring 23 a andmechanically coupled to a tens counting ring 23 b, as shown in FIG. 6 bymeans of a planetary gear. The operable coupling may be provided asshown in FIGS. 7 to 11, and like the display coupling members 21 and 22of other embodiments, it is connected to the coupler input member 6′such that it is secured against rotating, or can be coupled to thecoupler input member 6′. The display coupling member 23 cannot be movedin and counter to the direction of the coupler movement X relative tothe casing part 4. FIG. 1A shows the casing part 4 with the parts of theinjection apparatus accommodated in it, in a resting state in which theapparatus can be stored or the product dosage set. In order to preventthe coupler input member 6′ from the rotational drive movement, and tohold the drive member 25 in its tensed state, a rotational block or lockis formed between the coupler input member 6′ and the casing part 4. Inthe holding position of the coupler members 6′, 7′ and 9 shown, therotational block exists between a first blocking member 24 and a secondblocking member 34. The blocking member 24 is connected to the couplerinput member 6′, such that it is secured against rotating. The blockingmember 34 is connected to the casing part 4, such that it is securedagainst rotating but can be moved in and counter to the direction of thecoupler movement X relative to the casing part 4 and the coupler inputmember 6′. The facing areas of the blocking members 24 and 34, whichcontact each other in the blocking engagement, form a ratchet whichallows a rotational movement of the coupler input member 6′ which tensesthe drive member 25, and prevents a rotational movement in the oppositedirection.

For a second function connected with dosing and delivery, a shell outerarea of the blocking member 24 is provided with a thread, the threadedaxis of which is coaxial with the threaded axis of the piston rod 15. Astopping member 27 engages with this thread. The stopping member 27 isguided such that it can be linearly moved parallel to the threaded axisof the blocking member 24. In the exemplary embodiment, it can be movedin an axial groove on the inner shell area of the casing part 4. Theblocking member 24 forms a rotational stopper for the stopping member27, which limits the rotational movement of the coupler input member 6′which advances the piston rod 15. It forms another rotational stopperfor the stopping member 27, which determines the maximum dosage whichcan be delivered and set.

A triggering element 28 is provided for triggering the drive member 25.The triggering element 28 can be moved translationally relative to thecasing part 4 in the direction of the coupler movement X—in theexemplary embodiment, the advancing direction V and/or the distaldirection—and rotationally about the rotational axis of the couplerinput member 6′, which coincides with the threaded axis of the pistonrod 15, and is guided in these two movements by the casing part 4. Thetranslational movement in the distal direction establishes the couplerengagement between the coupler input member 6′ and the couplerintermediate member 7′ and releases the rotational block between theblocking members 24 and 34, which triggers the drive member 25, i.e.,delivery.

In another function, the triggering element 28 forms the dosing memberof another exemplary embodiment. Via multiple intermediate members, therotational movement of the triggering element 28 relative to the casingpart 4 sets the product dosage which can be delivered by the nextdelivery process. From the zero dosage position, which is shown in FIG.1A and determined by the stopping member 27 abutting the rotationalstopper of the blocking member 24 which limits the drive movement of thecoupler input member 6′, the dosage can be set by rotating thetriggering element 28 in the direction of the rotational direction arrowindicated. The rotational dosing movement of the triggering element 28is transferred onto the coupler input member 6′ via an inner part 29,which is connected to the triggering element 28 such that it is securedagainst rotating and shifting or is formed integrally with it, and aconnecting part 33. For transferring, the inner part 29 and theconnecting part 33 are in an engagement with each other, such that theyare secured against rotating, and the connecting part 33 is connected tothe coupler input member 6′, such that it is secured against rotating.The connecting part 33 also connected to the coupler input member 6′,such that it cannot be moved axially. For securing against rotating, theinner part 29 and the connecting part 33 are provided with an innertoothing (or other suitable meshing, linking or transferring means) 29 aand an outer toothing 33 a which interlock with each other in theresting state of the apparatus and can be axially shifted with respectto each other.

The triggering element 28 is arranged in the proximal end region of thecasing part 4 so as to be user-friendly. Its outer sleeve part surroundsthe casing part 4. A base of the triggering element 28 forms a distalend of the injection apparatus. For setting the dosage, the triggeringelement 28 can be operated as a turning button and is ribbed on itsouter shell area for this purpose. For triggering, it can be operated asa push button.

A stopper element 29 b projects from the inner part 29 towards aproximal facing area of the connecting part 33. In the resting state ofthe apparatus, a clear distance remains between the connecting part 33and the stopper element 29 b, which is complementarily just large enoughthat the rotational block between the inner part 29 and the connectingpart 33 is released during the triggering movement of the triggeringelement 28, before the stopper element 29 b terminates the relativemovement of the triggering element 28 relative to the connecting part 33by abutting contact.

The second blocking member 34 is tensed into the blocking engagementwith the blocking member 24 by means of a blocking spring 31. For thispurpose, the blocking spring 31 is supported in the direction of thecoupler movement X on the blocking member 34 and counter to the couplermovement X on a casing part 30 which is fixedly connected to the casingpart 4. Another spring 32, arranged between the inner part 29 and theblocking member 34, tenses the triggering element 28 relative to theblocking member 34 into a proximal end position.

In the resting state shown in FIG. 1A, the user sets the dosage byrotating the triggering element 28 in the direction of the rotationalarrow. During this rotational dosing movement, the triggering element 28slaves the connecting part 33 via the rotational block 29 a, 33 a, whichfor its part slaves the coupler input member 6′ which thus completes thesame rotational dosing movement as the triggering element 28. Rotatingthe coupler input member 6′ tenses the drive member 25. In theengagement with the thread of the blocking member 24, the stoppingmember 27 migrates from the stopper of the thread determining the zerodosage in the direction of the stopper determining the maximum dosage.

If the user has inadvertently set too high a dosage, it can be correctedby rotating the coupler input member 6′ back. For correcting the dosage,the triggering element 28 is moved in the proximal direction. In theresting state of the apparatus, the inner part 29 and the blockingmember 34 are in a slaving engagement with respect to a movement in theproximal direction.

The corresponding slaving means are indicated by 29 c and 34 a. Theslaving means 29 c formed by the inner part 29 and the slaving means 34a formed by the blocking member 34 grip behind each other and form alatch for a movement of the triggering element 28 in the proximaldirection. By pulling on the triggering element 28, the blocking member34 is thus also moved in the proximal direction and is thus releasedfrom the blocking engagement with the blocking member 24. As soon as therotational block is released, the user can correct the dosage by meansof the translational dosing movement of the triggering element 28 andthe still extant rotationally secured engagement between the inner part29 and the connecting part 33. As soon as the user releases thetriggering element 28, it snaps back together with the blocking member34 due to the effect of the blocking spring 31 in the distal directionand the blocking member 34 thus snaps back into the blocking engagementwith the blocking member 24. During the reverse movement, the userexpediently continues to hold the triggering element 28 fast, thoughonly to prevent relative rotational movements in the casing part 4. Inprinciple, however, it can also be allowed to snap back.

Once the desired dosage has been set, the apparatus is placed onto theskin at the desired administering location, and the injection needle isinjected. For injecting the needle, the user presses the triggeringelement 28 in the distal direction. A needle protecting sleeve, notshown in the figures, is correspondingly coupled to the triggeringelement 28. As soon as the injection needle has been placed, the drivemember 25 can be triggered and the product delivered by pressing furtheronto the triggering element 28. In the second phase of the triggeringmovement of the triggering element 28, which follows the phase forinjection, the triggering element 28 and therefore the inner part 29 ispressed further in the distal direction relative to the connecting part33, against the pressure of the spring 32, such that the rotationalblock 29 a, 33 a is released. The triggering element 28 can rotate idlyor freely. As soon as the rotational block 29 a, 33 a has been released,the stopper element 29 b passes into abutting contact with theconnecting part 33. In the third phase of the triggering movement whichthen follows, the triggering element 28 presses the connecting part 33and therefore the coupler input member 6′ via the stopper element 29 b,in the direction of the coupler movement X; in the exemplary embodiment,in the advancing direction V. Due to the effect of the spring force ofthe blocking spring 31, the blocking member 34 follows this movementuntil it abuts against the casing part 4. Before the blocking member 34reaches the abutting position, the coupler input member 6′ passes intothe coupler engagement with the coupler intermediate member 7′. Thecoupler input member 6′ presses the coupler intermediate member 7′ outof the frictional-lock blocking engagement with the decoupling member11′. Once the blocking engagement between the conical areas of the twomembers 7′ and 11′ has been released and the coupler engagementtherefore completely established, the blocking member 34 abuts thecasing part 4. In the final phase of the triggering movement which thenfollows, the triggering element 28 presses the blocking member 24 out ofthe blocking engagement with the blocking member 34.

As soon as the rotational block formed by the blocking members 24 and 34is released, the rotational drive movement of the coupler input member6′ is initiated due to the drive force of the drive member 25 and istransferred onto the coupler output member 9 via the coupler engagement.Because it is guided—such that it is secured against rotating—in thelinear guide 4 a, the piston rod 15 is moved, in the threaded engagementwith the coupler output member 9, in the advancing direction V, andproduct is delivered. This delivery movement is terminated by thestopping member 27 abutting the stopper of the thread of the blockingmember 24 determining the zero dosage.

FIG. 1B shows the injection apparatus when a zero dosage is set, in thecoupled state after the rotational block has been released, i.e. afterthe triggering element 28 has completely performed the triggeringmovement. If, advantageously, pressure is continuously exerted on thetriggering element, the triggering sequence described above progressesautomatically, from injecting to completely delivering the dosage set;for injecting, the casing is pressed against the surface of the skin.

FIG. 1C shows the injection apparatus after the reservoir 2 has beenemptied. The casing part 1 has already been removed from the casing part4. The piston rod 15 assumes its most distal position. The decouplingmember 11′ blocks the coupler input member 6′ in the position retractedfrom the coupler intermediate member 7′. The functionality of thedecoupling member 11′ corresponds to that in other embodiments. Unlikethe two first embodiments, however, the casing part 1 and the decouplingmember 11′ are not directly in a guiding engagement with each other, butrather via an adaptor structure 40. The adaptor structure 40 is a sleevewhich is fixed in the casing part 4 in and counter to the direction ofthe coupler movement X in the connecting portion, but can be rotatedabout the central longitudinal axis of the casing part 4. The adaptorstructure 40 forms a guiding curve 40 a either as a cavity on or abreach in its shell area facing the decoupling member 11′. The guidingcurve 40 a exhibits the course of a threaded portion. The lengthmeasured over the circumference and the pitch of the guiding curve 40 ameasured with respect to the central longitudinal axis of the casingpart 4 are dimensioned such that the decoupling member 11′ is moved intothe decoupling position shown in FIG. 1B by a quarter to a halfrevolution of the adaptor structure 40 relative to the decoupling member11′. The movement of the decoupling member 11′ exhibits an axial lengthwhich corresponds to the length X of the complete coupler movement. Forgenerating the axial movement, the decoupling member 11′ engages via itsengaging element 12 with the guiding curve 40 a. In this respect,reference is made to the statements regarding the first describedexemplary embodiment.

When connecting the casing parts 1 and 4, the adaptor structure 40 formsa linear guide for the casing part 1. The casing part 1 is inserted intothe adaptor structure 40, wherein a slight frictional lock andcorrespondingly a sliding guide for the casing part 1 exists. The casingpart 1 cannot be rotated about the central longitudinal axis of thecasing part 4 relative to the adaptor structure 40. The engagement,which accordingly is rotationally secured, is established right at thebeginning of inserting the casing part 1 into the adaptor structure 40.Once the casing part 1 has been inserted until it abuts against thecasing part 4, i.e., once the coupler is accommodated at 4 a, the casingpart 1 is rotated relative to the casing part 4 and slaves the adaptorstructure 40 during this rotational movement, until the engaging element12 of the decoupling member 11′ abuts the end of the guiding curve 40 a.In some embodiments, the rotational movement of the casing part 1 ispreferably not possible until its axial abutting position, for whichpurpose a rotational block acting up until the abutting position canalso be formed between the casing parts 1 and 4.

FIG. 2, as also FIG. 3, shows a cross-section of a life timer 100 whichis integrated in the triggering element or dosing button 28 andconnected to the threaded rod or piston rod 15 by means of a connectingpiece 101. If the ampoule inserted into the injection device is full,then the switch 102 of the life timer can be activated via the pistonrod 15 and the connecting piece 101, such that the LED 103 a is brieflyilluminated green. A chip 104 is provided on the circuit board 105 a forevaluating the signals generated by the contact switch 102 and forcontrolling the LED 103 a. The power necessary is provided by a battery106 which is fastened to the circuit board 105 a by means of a contactbow 107, wherein the life timer consisting of the components 102 to 107is mounted in the receptacle 108. The elements of the one embodiment ofthe life timer, shown in cross-section in FIG. 2, are shown individuallyin FIG. 3. A time detection unit is integrated in the chip 104 and isstarted by the switch 102 by a signal, once an operating process hasbeen detected for the first time. Once the maximum service life, forexample, three years, stored in the chip has elapsed, the LED 103 a iscontrolled such that it is illuminated red or blinks in order to signalto the user that he/she should no longer use the injection device andhas to replace it. Additionally or alternatively, the number of ampoulechanges, which can also be detected using the switch 102, can also beadduced in order to determine the end of the service life.

FIG. 4 shows an electronics sub-assembly integrated into the injectiondevice, comprising an LCD display 110 which is illuminated from the rearside with green light by an LED 103 b when the injection pen is operatedwithin the service life, and with red light when the injection pen isoperated outside a service life which may be defined or is ascertainedin accordance with its operation. A spur wheel or toothed ring 111meshes with a toothing of the coupler sleeve or coupler input member 6,6′ and transfers a rotational movement of the coupler input member 6, 6′to the encoder 112 a, wherein the signal generated by the encoder 112 ais processed by electronics and outputted for display on the LCD 110 tobe read by the user. Since the coupler sleeve or coupler input member 6,6′ is moved as well during the setting process and during a deliveryprocess, the encoder 112 a coupled to the coupler sleeve 6 via the spurwheel 111 can always detect what dosage is still provided for dispensingfrom the injection device, such that the display on the LCD 110regresses during the delivery process.

Aside from the coupler sleeve, a sensor or encoder can also be directlyor indirectly coupled or connected to other elements of the pen providedfor setting the dosage or for the delivery movement, such as a countingring, the blocking member 24 or the connecting part 33.

FIG. 5A shows a perspective view of another embodiment of an electronicreal-time display, which is shown in cross-section in FIG. 5B and in atop view in FIG. 5C, wherein a toothed ring 114 is provided, such thatit is secured against rotating, on a setting or dosing member of theinjection device (not shown), and a toothed wheel 113 coupled to anencoder or rotational coder 112 b having no stopper engages with saidtoothed ring 114 in order to detect a rotational movement of the dosingmember and to display a dosage corresponding to the rotational movementon the LCD display 110. The encoder 112 b could also be coupled to thecoupler input member by means of a toothed wheel, as shown in FIG. 4.

FIG. 6 shows an embodiment of a mechanical coaxial real-time display,comprising a units counting ring 23 a and a tens counting ring 23 b asbriefly described above. In the embodiment shown, the drive disc 120connected to the coupler sleeve 6, 6′ (not shown in FIG. 6) comprisesthree bearings 120 a for planetary toothed wheels 121 which are drivenby the drive disc 120. The planets 121 drive the units counting ring 23a which comprises an outer toothing 23 c serving as a sun wheel which iscoaxially offset and has a smaller diameter than the units counting ring23 a. On a hollow wheel 122, a bearing is provided for a couplingtoothed wheel 123 which after each full revolution of the units countingring 23 a engages with the inner toothing 23 d provided only on apartial region of the units counting ring 23 a, in order to rotate thetens counting ring 23 b further by 36 degrees. The hollow wheel 122serves as a bearer for the unit shown in FIG. 6 and is held in thecasing of the injection device. The rotational direction of the unitscounting ring 23 a and the tens counting ring 23 b corresponds to therotational direction of the drive disc 120 coupled or connected to thecoupler sleeve, such that a mechanical real-time display can be realisedwhich continuously counts during the setting process, possiblecorrections to the setting and during the delivery process, and displaythe amount of the dosage still available for delivery after setting, inreal-time.

FIG. 7 shows an embodiment in which the concept described with referenceto FIG. 4 is realised not by an electronic display, but by a mechanicaldisplay, wherein the coupler sleeve is guided by a circuit board 105 band comprises teeth, texture or a toothing on its outer surface, withwhich the spur wheel 111 engages, as described with reference to FIG. 4.The outer toothing of the coupler sleeve is coupled to a toothed wheelformed as a slaving means 130 which transfers the rotational movement ofthe coupler sleeve onto an inner toothing 23 e of the units countingring 23 a, wherein the units counting ring 23 a is coupled to the tenscounting ring 23 b by means of the inner toothing 23 d provided onlyover a part of the inner circumference, as described with reference toFIG. 6, in order to realise a real-time display. The units and tenscounting rings 23 a and 23 b are transparent, such that a red or greenlight emitted by the LED 103, for indicating whether the injectiondevice can still be used (green) or the service life has elapsed (red),can be perceived by a user reading the setting on the counting rings 23a, 23 b.

FIG. 8 shows a cross-section of the device shown in FIG. 7, whenassembled, wherein a section along the line indicated by III-III isshown in FIG. 9 and along the line indicated by IV-Iv in FIG. 10. Thedetail X in FIG. 9 is shown in FIG. 11.

Embodiments of the present invention, including preferred embodiments,have been presented for the purpose of illustration and description.They are not intended to be exhaustive or to limit the invention to theprecise forms and steps disclosed. Obvious modifications or variationsare possible in light of the above teachings. The embodiments werechosen and described to provide the best illustration of the principalsof the invention and its practical application, and to enable one ofordinary skill in the art to utilize the invention in variousembodiments and with various modifications as are suited to theparticular use contemplated. All such modifications and variations arewithin the scope of the invention as determined by the appended claimswhen interpreted in accordance with the breadth they are fairly,legally, and equitably entitled.

1. A method for determining the service life of an injection device,comprising the steps of: providing a service life of the injectiondevice, the service life having a beginning and an end; establishing thebeginning of the service life by using one or more sensors for detectingwhen the injection device is set or changed; generating a signal whichsignals the end of the service life; and providing an output deviceassociated with the injection device that outputs at least one of anoptical, acoustic or tactile signal which indicates to a user that theservice life is at the end.
 2. The method according to claim 1, whereinthe optical, acoustic or tactile signal is outputted continuously afterone of the end of the service life or for a predetermined time periodafter detecting an operating process.
 3. The method according to claim2, wherein an operational process of the injection device is detectedand used to calculate the service life.
 4. The method according to claim3, wherein the operational process comprises the number of injectionprocesses performed.
 5. The method according to claim 1, furthercomprising the step of providing a controller for controlling any of theoperating processes of the injection device.
 6. The method according toclaim 5, further comprising software for the controller.